Peptide Library

Human study PLS-00233

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration

Single-arm trial · 40 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degenerationregistry entry · NCT02848313 (COMPLETED, results posted, planned enrollment 40)

Design and participants

Design
Single-arm trial
Population
Subjects with intermediate age-related macular degeneration
Conditions
Age-Related Macular Degeneration
Planned enrollment (registry)
40
Enrolled
40
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • Subcutaneous elamipretide (intervention) · elamipretide · Elamipretide (also listed as MTP-131; Bendavia), open-label · subcutaneous · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Safety and tolerability

unclear outcome · safety · Safety and tolerability of subcutaneous elamipretide per study title; specific measures not given in record

  • No results reported.

Adverse events

None reported. That is not evidence of safety, and how safety was monitored isn’t described.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • no control group: The record describes an open-label phase 1 study with no comparator or placebo arm, so adverse events cannot be attributed to elamipretide versus background.
  • inadequate blinding: The study is explicitly open-label, so participants and assessors knew treatment status, which may affect reporting of tolerability outcomes.
  • small or imprecise: Registry lists an actual enrollment of 40 participants, too few to detect uncommon adverse events reliably.
  • other: Only registry fields are available. Although results are flagged as posted, no outcome or adverse event data appear in the record, so no results could be extracted.
  • inappropriate population: Participants had intermediate age-related macular degeneration, not Barth syndrome or primary mitochondrial myopathy addressed by the efficacy claims.
  • abstract only: Only the registry entry is available. It gives no outcome data, adverse event data, or methods, although the registry says results exist.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

Where each value comes from

  • arms: NCT NCT02848313, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT02848313, title (study title (open-label, phase 1)) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT02848313, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT02848313, registry (enrollment, has_results and phases fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT02848313, title (study title (safety and tolerability)) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT02848313, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT02848313, registry (conditions field) · extracted by AI (automated, not verified by a person)

  • Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).